Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 040794

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METHYLPREDNISOLONE ACETATE (METHYLPREDNISOLONE ACETATE)
40MG/ML Marketing Status: Prescription

Active Ingredient: METHYLPREDNISOLONE ACETATE
Proprietary Name: METHYLPREDNISOLONE ACETATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 40MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A040794
Product Number: 001
Approval Date: Mar 5, 2009
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information

METHYLPREDNISOLONE ACETATE (METHYLPREDNISOLONE ACETATE)
80MG/ML Marketing Status: Prescription

Active Ingredient: METHYLPREDNISOLONE ACETATE
Proprietary Name: METHYLPREDNISOLONE ACETATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 80MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A040794
Product Number: 002
Approval Date: Mar 5, 2009
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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